The present invention relates to a new and improved bandage for the treatment and rehabilitation of scar tissue wherein the bandage comprises a reinforced silicone gel sheeting.
When skin or dermis has been traumatized by cutting or burning, scar tissue is formed. In most cases, a small cut or burn area will result in a correspondingly small amount of scar tissue which is not readily discernable to a casual observer. In other cases, where the traumatized area is large and/or lengthy, scarring and scar tissue are quite apparent to a casual observer. This can not only be embarrassing for the person who is scarred, but can be a distraction for the casual observer. And, this can be particularly embarrassing to a person who has had elective surgery for cosmetic considerations. The problem is compounded when, over time, scar tissue tends to darken, become hypertrophic (thick) and project outwardly from the skin surface, thus becoming more apparent. Additionally, if the scar tissue happens to overlay a skeletal joint, movement of the joint is often painful and restricted. In the past, such complications were overcome by covering the scar tissue with clothing, make-up, or avoiding contact with other people. This strategy is often not possible nor desirable. Scar tissue and the tissue adjacent thereto can often become hyper-sensitive to contact with clothing, and often, a person will not cover scar tissue to the detriment of socialization. In some instances, a person might not be able to tolerate the application of make-up over scar tissue, again to the detriment of socialization. In other instances, a person may be required to wear a certain type or style of clothing which does not cover scar tissue locations.
Many medical care givers have recognized many of the problems associated with scar tissue and now include scar tissue management as part of the overall treatment of patients.
Silicone gels in the form of sheets have been used in the management of new scar tissue and hypertrophic keloid scarring resulting from elective surgery such as plastic surgery. It has been found that when the gels are positioned against scar tissue and pressure is applied thereto, the formation of hypertrophic scar tissue and attendant coloration can be reduced, resulting in a more normal appearance. Silicone gel sheets have the advantage over traditional bandages in that the gel adapts itself readily to the contours of the human body.
In the past, it has been found necessary to make silicone gels quite thick in order to prevent the gel from fragmenting during application and use. Although in the past, fiber nets have embedded in the silicone gel in an attempt to improve the strength and ease of handling of the silicone gel sheets, these attempts have not proved fruitful. See Pocknell, U.S. Pat. No. 4,991,574 at column 1, lines 66-68.
Additionally, gel sheets of the type that utilize silicone are tacky to the touch, both on the inner, body contacting surface and the exterior surface. Having a body contacting surface which is tacky to the touch is advantageous and desirable. Having an exterior which is tacky to the touch is not. A disadvantage of having a tacky exterior is that articles of clothing tend to adhere to the gel sheet. This presents several problems. One problem is that often the gel sheet adheres to an article of clothing with greater force than it adheres to the skin. Thus, when the article of clothing is removed, the gel sheet is removed from the body. Another problem is that articles of clothing will adhere to the gel sheet and prevent normal range of motion.
An additional problem encountered with gel sheets which are tacky to the touch is that they tend to become soiled more quickly.
The present invention solves the above problems by layering a polyester mesh fabric on top of a silicone gel sheet and then covering the mesh fabric with a layer of silicone which serves as a sealant and an adhesive for the mesh fabric by projecting through the holes in the fabric to bind the fabric to the silicone sheet. Thus, the mesh fabric is not embedded in the silicone sheet, but is layered on the sheet on the surface opposite that contacting the skin.